FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge LI

Primary DI
00842768005367
Brand
Dimension® Flex® reagent cartridge LI
Company
Siemens Healthcare Diagnostics Inc.
Model
10444939
Catalog number
DF132
Device description
Lithium Flex® reagent cartridge, 80 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIHFLAME PHOTOMETRY, LITHIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIHFlame Photometry, LithiumClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011033000DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132Dade Behring, Inc.2001-06-07JIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005367PrimaryGS10
00630414004266Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005367008427680053678427680053670842768005367
00630414004266006304140042666304140042660630414004266

GMDN Terms#

Term, Definition table
TermDefinition
Lithium therapeutic drug monitoring IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00811403019984ProLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JIH2023-06-05
00386100002282ISE Reagent PackMEDICA CORPORATIONJIH2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJIH2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJIH2019-02-14
00386100001667ISE Lithium Electrode MEDICA CORPORATIONJIH2018-12-11
00386100002480Lithium Electrode MEDICA CORPORATIONJIH2018-12-11
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJIH2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJIH2018-12-11
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00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJIH2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003074Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003104Na/K/Li Solution PackMEDICA CORPORATIONJIH2018-12-04
00386100003005Lithium ElectrodeMEDICA CORPORATIONJIH2018-11-08
00630414451824RAPIDChem® 754 Na+K+Li+ Reagent ModuleSiemens Healthcare Diagnostics Inc.JIH2016-09-24
00630414451862RAPIDChem® 700 Lithium SensorSiemens Healthcare Diagnostics Inc.JIH2016-09-24
04015630028795Roche 9180 Lithium ElectrodeRoche Diagnostics GmbHJIH2016-09-20
10758750004720VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26
10758750009466VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JIH2016-08-26